Bowel cleansing MedDRA version: 17.1 Level: PT Classification code 10066943 Term: Bowel preparation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: PICOLAX (PICOPREP)
Product Name: PICOPREP
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: SODIUM PICOSULFATE
CAS Number: 10040-45-6
Concentration unit: mg milligram(s)
C
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female, 18 years of age or above, being scheduled to undergo elective colonoscopy •Subjects must have had more than or equal to 3 spontaneous bowel movements (i.e. without use of any laxative within 24 hours before the bowel movement, with the exception for bulk-forming laxatives (ACT code A06AC)) per week for one month prior to the colonoscopy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 118
Exclusion criteria
Exclusion criteria: • Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.) • Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD) • Any prior colorectal surgery, excluding appendectomy, haemorrhoid surgery or prior endoscopic procedures • Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudoobstruction, hypomotility syndrome) • Ascites • Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus) • Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass) • Severely reduced renal function (Glomerular filtration rate (GFR) <30 (mL/min/1.73 m2)) • The subject is a pregnant (positive urine pregnancy test at Visit 1 or Visit 2) woman. Women of childbearing potential (defined, for the purpose of this trial, as all females post-puberty, not postmenopausal =2 years, or not surgically sterile) who do not agree to use one of the following methods of birth control from the day of signing the Informed Consent Form until End of Trial Visit are excluded: a.Transdermal patch b.Hormonal contraception (i.e., oral, implant, or injectable contraceptive) c.Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm plus spermicide, etc.) d.Maintenance of a monogamous relationship with a male who has been surgically sterilised by vasectomy e.Sexual abstinence • The subject is a breast-feeding or lactating woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority of a tailored PICOPREP dosing schedule compared to the day-before PICOPREP dosing schedule in overall colon cleansing in preparation for colonoscopy;Secondary Objective: • To demonstrate the efficacy of ascending, mid (transverse, descending) and recto-sigmoid colon cleansing of a tailored PICOPREP dosing schedule • To demonstrate convenience and satisfaction of a tailored PICOPREP dosing schedule compared to the day-before PICOPREP dosing schedule • To demonstrate the impact of a tailored PICOPREP dosing schedule compared to the day-before PICOPREP dosing schedule on health economics • To evaluate safety and tolerability through the collection of adverse events (AEs), clinical laboratory tests and vital signs ;Primary end point(s): • Overall colon cleansing procedure measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules;Timepoint(s) of evaluation of this end point: During colonoscopy at visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary endpoint: •Ascending colon cleansing by percentage of subjects classified as success , i.e. excellent or good, measured by the Ottawa Scale at Visit 3 performed by a colonoscopist blinded to the dosing schedules Safety: •Frequency and intensity of adverse events •Clinically significant changes in vital signs (pulse, blood pressure [BP]) •Clinically significant changes in laboratory values ;Timepoint(s) of evaluation of this end point: Timepoints for the secondary end points: Visit 3 Safety: AEs collected at all visits and telephone contact Vital signs measured at all visits Lab parameters measured at visit 1,3 and 4 | — |
Countries
France, Germany, Netherlands
Contacts
Public ContactClinical Development Support
Ferring Pharmaceuticals A/S
Outcome results
None listed